Package leaflet: Information for the use
Ledipasvir and Sofosbuvir tablets 90mg/400mg
Read all of this leaflet carefully before you start t0aking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Ledipasvir and Sofosbuvir is and what it is used for
2. What you need to know before you take Ledipasvir and Sofosbuvir
3. How to take Ledipasvir and Sofosbuvir
4. Possible side effects
5. How to store Ledipasvir and Sofosbuvir
6. Contents of the pack and other information
1. What Ledipasvir and Sofosbuvir is and what it is used for
Ledipasvir and Sofosbuvir is a medicine that contains the active substances ledipasvir and sofosbuvir in a single tablet. It is given to treat chronic (long-term) hepatitis C virus infection in adults and adolescents 12 to less than 18 years of age.
Hepatitis C is a virus that infects the liver. The active substances in the medicine work together by blocking two different proteins that the virus needs to grow and reproduce itself, allowing the infection to be permanently eliminated from the body.
Ledipasvir and Sofosbuvir is sometimes taken with another medicine, ribavirin.
It is very important that you also read the leaflets for the other medicines that you will be taking with Ledipasvir and Sofosbuvir. If you have any questions about your medicines, please ask your doctor or pharmacist.
2. What you need to know before you take Ledipasvir and Sofosbuvir
Do not take Ledipasvir and Sofosbuvir
- If you are allergic to ledipasvir, sofosbuvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
- If this applies to you, do not take Ledipasvir and Sofosbuvir and tell your doctor immediately.
- If you are currently taking any of the following medicines:
- rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis);
- St. John?s wort (herbal medicine used to treat depression);
- carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures);
- rosuvastatin (a medicine used to treat high cholesterol).
Warnings and precautions
Your doctor will know if any of the following conditions apply to you. These will be considered before treatment with Ledipasvir and Sofosbuvir is started.
- other liver problems apart from hepatitis C, for instance
- if you are awaiting a liver transplant;
- if you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
- kidney problems or if you are on kidney dialysis since Ledipasvir and Sofosbuvir has not been fully tested in patients with severe kidney problems;
- ongoing treatment for HIV infection, since your doctor may want to monitor you more closely.
Talk to your doctor or pharmacist before taking Ledipasvir and Sofosbuvir if:
- you currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if you have taken this medicine).
- you have diabetes. You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Ledipasvir and Sofosbuvir. Some diabetic patients have experienced low sugar levels in the blood (hypoglycemia) after starting treatment with medicines like Ledipasvir and Sofosbuvir.
Tell your doctor immediately if you are taking any medicines for heart problems and during treatment you experience:
- shortness of breath
- light-headedness
- palpitations
- fainting
Blood tests
Your doctor will test your blood before, during and after your treatment with Ledipasvir and Sofosbuvir. This is so that:
- Your doctor can decide if you should take Ledipasvir and Sofosbuvir and for how long;
- Your doctor can confirm that your treatment has worked and you are free of the hepatitis C virus.
Children and adolescents
Do not give this medicine to children under 12 years of age. The use of Ledipasvir and Sofosbuvir in children has not yet been studied.
Other medicines and Ledipasvir and Sofosbuvir
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Warfarin and other similar medicines called vitamin K antagonists used to thin the blood. Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot.
Your liver function may change with the treatment of hepatitis C and therefore may affect other medications (e.g. medicines used to suppress your immune system, etc.). Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Ledipasvir and Sofosbuvir.
If you are not sure about taking some other medicines, talk to your doctor or pharmacist.
Some medicines should not be taken with Ledipasvir and Sofosbuvir.
- Do not take any other medicine that contains sofosbuvir, one of the active substances in Ledipasvir and Sofosbuvir.
- Tell your doctor or pharmacist if you are taking any of the medicines below:
- amiodarone used to treat irregular heartbeats;
- tenofovir disoproxil fumarate or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection;
- digoxin used to treat heart conditions;
- dabigatran used to thin the blood;
- statins used to treat high cholesterol;
- rifapentine (an antibiotic used to treat infections, including tuberculosis);
- oxcarbazepine (a medicine used to treat epilepsy and prevent seizures);
- tipranavir (used to treat HIV infection).
Taking Ledipasvir and Sofosbuvir with any of these may stop your medicines from working properly, or make any side effects worse. Your doctor may need to give you a different medicine or adjust the dose of medicine you are taking.
- Get advice from a doctor or pharmacist if you take medicines used to treat stomach ulcers, heartburn or acid reflux. This includes:
- antacids (such as aluminum/magnesium hydroxide or calcium carbonate). These should be taken at least 4 hours before or 4 hours after Ledipasvir and Sofosbuvir;
- proton pump inhibitors (such as omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole). These should be taken at the same time as Ledipasvir and Sofosbuvir. Do not take proton pump inhibitors before Ledipasvir and Sofosbuvir. Your doctor may give you a different medicine or adjust the dose of the medicine you are taking;
- H2-receptor antagonists (such as famotidine, cimetidine, nizatidine or ranitidine). Your doctor may give you a different medicine or adjust the dose of the medicine you are taking.
These medicines can decrease the amount of ledipasvir in your blood. If you are taking one of these medicines your doctor will either give you a different medicine for stomach ulcers, heartburn or acid reflux, or recommend how and when you take that medicine.
Pregnancy and contraception
The effects of Ledipasvir and Sofosbuvir during pregnancy are not known. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy must be avoided if Ledipasvir and Sofosbuvir is taken together with ribavirin. Ribavirin can be very damaging to an unborn baby. Therefore, you and your partner must take special precautions in sexual activity if there is any chance for pregnancy to occur.
- You or your partner must use an effective birth control method during treatment with Ledipasvir and Sofosbuvir together with ribavirin and for some time afterward. You must read the ?Pregnancy? section in the ribavirin package leaflet very carefully. Ask your doctor for an effective contraceptive method suitable for you.
- If you or your partner become pregnant during Ledipasvir and Sofosbuvir and ribavirin treatment or in the months that follow, you must contact your doctor immediately.
Breast-feeding
Do not breast-feed during treatment with Ledipasvir and Sofosbuvir. It is not known whether ledipasvir or sofosbuvir, the two active substances of Ledipasvir and Sofosbuvir, pass into human breast milk.
Driving and using machines
Do not drive or operate machines if you feel tired after taking your medicine.
Ledipasvir and Sofosbuvir contains lactose
- If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Ledipasvir and Sofosbuvir contain sunset yellow FCF aluminum lake which can cause allergic reactions
- Tell your doctor if you are allergic to sunset yellow FCF aluminum lake, also called ?E110? before taking this medicine.
3. How to take Ledipasvir and Sofosbuvir
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Recommended dose
The recommended dose is one tablet once a day. Your doctor will tell you for how many weeks you should take Ledipasvir and Sofosbuvir.
Swallow the tablet whole by or without food. Do not chew, crush or split the tablet as it has a very bitter taste. Tell your doctor or pharmacist if you have problems swallowing tablets.
If you are taking an antacid, take it at least 4 hours before or at least 4 hours after Ledipasvir and Sofosbuvir.
If you are taking a proton pump inhibitor, take it at the same time as Ledipasvir and Sofosbuvir. Do not take it before Ledipasvir and Sofosbuvir.
If you are sick (vomit) after taking Ledipasvir and Sofosbuvir it may affect the amount of Ledipasvir and Sofosbuvir in your blood. This may make Ledipasvir and Sofosbuvir work less well.
- If you are sick (vomit) less than 5 hours after taking Ledipasvir and Sofosbuvir, take another tablet.
- If you are sick (vomit) more than 5 hours after taking Ledipasvir and Sofosbuvir, you do not need to take another tablet until your next scheduled tablet.
If you take more Ledipasvir and Sofosbuvir than you should
If you accidentally take more than the recommended dose you should contact your doctor or nearest emergency department immediately for advice. Keep the tablet bottle with you so that you can easily describe what you have taken.
If you forget to take Ledipasvir and Sofosbuvir
It is important not to miss a dose of this medicine.
If you do miss a dose, work out how long it is since you last took your Ledipasvir and Sofosbuvir:
- If you notice within 18 hours of the time you usually take Ledipasvir and Sofosbuvir, you must take the tablet as soon as possible. Then take the next dose at your usual time.
- If it?s 18 hours or more after the time you usually take Ledipasvir and Sofosbuvir, wait and take the next dose at your usual time. Do not take a double dose (two doses close together).
Do not stop taking Ledipasvir and Sofosbuvir
Do not stop taking this medicine unless your doctor tells you to. You must complete the full course of treatment to give the medicine the best chance to treat your hepatitis C virus infection.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine may cause side effects. If you take Ledipasvir and Sofosbuvir you may get one or more of the side effects below:
Very common side effects
(may affect more than 1 in 10 people)
- headache
- feeling tired
Common side effects
(may affect up to 1 in 10 people)
- rash
Other effects that may be seen during therapy with Ledipasvir and Sofosbuvir
The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
- swelling of the face, lips, tongue or throat (angioedema).
Other effects that may be seen during treatment with sofosbuvir:
The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
- a wide-spread severe rash with peeling skin which may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens-Johnson syndrome).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Ledipasvir and Sofosbuvir
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and carton after ?EXP?. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Ledipasvir and Sofosbuvir contains
- The active substances are ledipasvir and sofosbuvir. Each film-coated tablet contains 90mg ledipasvir and 400mg sofosbuvir.
- The other ingredients are
Tablet core:
Copovidone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate
Film-coating:
Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, sunset yellow FCF aluminum lake
What Ledipasvir and Sofosbuvir looks like and contents of the pack
Each bottle contains a silica gel desiccant (drying agent) that must be kept in the bottle to help protect your tablets. The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
The following pack sizes are available:
- outer cartons containing 1 bottle of 28 film-coated tablets
- outer cartons containing 3 bottles of 28 (84) film-coated tablets. Not all pack sizes may be marketed.
7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)